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Personalized Treatment for Patients With Premature Ventricular Beats

Personalized Treatment for Patients With Premature Ventricular Beats

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04617717
Enrollment
224
Registered
2020-11-05
Start date
2020-09-30
Completion date
2040-07-31
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Premature Complexes

Brief summary

Frequent premature ventricular beats (PVBs) are common, negatively affects the quality of life for many patients, and can lead to impaired contractile function. Rule-out of structural heart disease is key in the assessment of PVBs. Cardiac MR has a high sensitivity for structural heart disease, but the diagnostic gain from this resource-demanding procedure in the work-up of patients with PVBs is unknown. There is a need to establish the role of MR in the evaluation of patients with PVBs to improve diagnostic efficacy, establish treatment strategies, and promote further research. This project will answer three key questions: 1) What is the diagnostic gain from cardiac MR in patients with PVBs? 2) Is MR the real gold standard to rule-out structural heart disease in patients with PVBs? 3) Can non-invasive heart rate parameters guide the strategy for induction of PVBs during invasive electrophysiological procedures?

Interventions

PROCEDUREInvasive cardiac electrophysiological study and ablation therapy

Invasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation

DIAGNOSTIC_TESTCardiopulmonary exercise testing

Standard ergometer bicycle test

DIAGNOSTIC_TESTCardiac MRI

Cardiac MRI with cine-imaging and late-gadolinium enhancement

DIAGNOSTIC_TESTHolter monitoring

24h 5 lead or 12 lead ECG recording

DIAGNOSTIC_TESTTransthoracic echocardiography

2D echocardiography

DIAGNOSTIC_TESTCoronary angiography

Conventional invasive coronary angiography or CT angiography as indicated

Sponsors

University of Oslo
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Patients referred for PVC ablation

Design outcomes

Primary

MeasureTime frameDescription
MRI-based evidence of structural heart disease3-5 yearsEvidence of structural heart disease from MRI compared to echocardiography
PVC induction vs PVC/HR-relationship3-5 yearsCorrelation of method for induction of PVCs during invasive procedure vs PVC/HR relationship during CPET
EPS-based evidence of structural heart disease3-5 yearsEvidence of structural heart disease from invasive electrophysiology vs MRI and echo

Countries

Norway

Contacts

Primary ContactMathis K Stokke, MD PhD
m.k.stokke@medisin.uio.no90696883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026